Senior Statistical Programming Lead – SDTM/ADaM, Remote

Ascendis Pharma A/S; Palo Alto (CA); Remote; USD 170,000 - 180,000; Full time

Benefits offered by this job

401(k) match

Medical/Dental/Vision insurance

Life and AD&D insurance

Disability benefits

Pet Insurance

Employee Assistance Program

Job summary

Ascendis Pharma in Palo Alto, CA is seeking a Senior Manager, Statistical Programming to provide timely and strategic programming support to clinical study teams. You will lead programming deliverables from study start through regulatory submission while developing departmental tools.

The role requires CDISC SDTM/ADaM expertise, SAS programming proficiency, and strong leadership to collaborate with Biostatistics, Data Management, and Medical Writing. Remote work options may apply.

Qualifications

• Bachelor’s degree in Statistics, Mathematics, Computer Science, or related field with 10+ years programming in pharma/biotech.
• Master’s degree with 7+ years of relevant programming experience.
• Proven experience as a lead programmer for clinical trials and complex technical projects.
• Excellent knowledge of CDISC standards, including SDTM and ADaM.
• Understanding of the clinical drug development process and regulatory requirements.
• Proficiency in SAS programming, including reusable macros.
• Familiarity with R, Python, Git, VB.
• Experience contributing to departmental tools (macro libraries, templates, automation).
• Strong communication, self-motivation and attention to detail.

Responsibilities

• Serve as the Statistical Programming Lead for clinical trials, overseeing all programming deliverables from study start to submission.
• Represent Statistical Programming in cross-functional study team meetings and contribute to project planning and timelines.
• Develop, validate, and maintain SDTM and ADaM datasets following CDISC standards and study specifications.
• Generate or validate tables, listings, and figures (TLFs) for CSR, ISS/ISE, and regulatory submissions.
• Support statisticians with planned and ad hoc analyses.
• Develop and maintain reusable macros, templates, and specification tools for consistent programming across studies.
• Collaborate with Biostatistics, Data Management, and Medical Writing to ensure high-quality deliverables.

Skills

SAS programming

CDISC SDTM/ADaM

Lead programmer

R

Python

Git

VB

SAS macros

Education

Bachelor’s degree in Statistics, Mathematics, Computer Science, or related field

Master’s degree in a related field

Tools

SAS macros

Specification templates

Job description

Ascendis Pharma in Palo Alto, CA is seeking a Senior Manager, Statistical Programming to provide timely and strategic programming support to clinical study teams. You will lead programming deliverables from study start through regulatory submission while developing departmental tools.

The role requires CDISC SDTM/ADaM expertise, SAS programming proficiency, and strong leadership to collaborate with Biostatistics, Data Management, and Medical Writing. Remote work options may apply.